Vascular puncture seal anchor nest

FIELD OF THE INVENTION

p-0002The present invention relates to medical devices, and, more particularly, to a vascular puncture sealing apparatus with nest features to aid in anchor function.

BACKGROUND OF THE INVENTION

p-0003Various medical procedures, particularly cardiology procedures, involve accessing a corporeal vessel or other lumen through a percutaneous sheath. Insertion of the sheath necessarily requires a hole or opening in the vessel wall so that a medical procedure can be performed through the sheath. After the particular medical procedure has been performed, the sheath must eventually be removed from the vessel and the access hole in the vessel wall must be closed.

p-0004A number of prior vascular closure devices have been developed to close the hole or puncture in the vessel wall. Closing the hole typically involves packing a resorbable sealing plug at the hole or sandwiching the hole between the sealing plug and an anchor. Examples of prior vascular closure devices are described in U.S. Pat. Nos. 6,179,863; 6,090,130; and 6,045,569 and related patents that are hereby incorporated by reference.

p-0005Placing the sealing plug often comprises several steps. First, a puncture site is located. A puncture locator is placed in and through the insertion sheath such that an inlet port in the puncture locator resides outside a distal end of the insertion sheath a predetermined distance. The insertion sheath and puncture locator are inserted through the puncture into a blood vessel. As the distal end of the puncture locator penetrates the blood vessel, blood flows into the inlet port and out of a drip hole via a flow path through the puncture locator.

p-0006Blood exiting the drip hole indicates that the puncture locator and insertion sheath have just penetrated the blood vessel. To ensure proper placement of the insertion sheath and subsequently the closure device, the insertion sheath and puncture locator are normally backed out of the vessel until blood stops flowing from the drip hole. Next, the insertion sheath and puncture locator are re-inserted into the blood vessel until blood starts flowing again from the drip hole. Proper depth of penetration and location of the assembly is established by continuing to insert an additional predetermined distance, for example, an operator often inserts the assembly 1 to 2 centimeters further if the blood vessel is a femoral artery. Once the insertion sheath is properly located, the puncture locator is removed and the vascular closure device may be inserted through the sheath and into to the blood vessel.

p-0007An anchor at a distal end of the vascular closure device is then deployed within the artery. The anchor is initially aligned with a longitudinal axis of the closure device in a covered nest of the closure device. The anchor is deployed by removing a cover from the anchor and inserting the anchor through the insertion sheath, which allows the anchor to rotate and align itself with an interior wall of the blood vessel. However, sometimes when the anchor is deployed, it tends to remain in or reenter the sheath instead of rotating and aligning with the blood vessel. This phenomenon is termed “shuttling.” Shuttling disables the function, and negates the benefit, of the device. Therefore, it is desirable to have an apparatus that reduces or eliminates anchor shuttle so that the closure device will function as expected.

SUMMARY OF THE INVENTION

p-0008In one of many possible embodiments, the present invention provides a tissue puncture closure assembly comprising a closure device for partial insertion into and sealing of an internal tissue wall puncture. The closure device includes a filament extending from a first end of the closure device, a nest comprising a first surface, an anchor for insertion through the tissue wall puncture seated in the nest and attached to the filament at the first end of the closure device, a sealing plug slidingly attached to the filament adjacent to the anchor, and a gap between the nest and a portion of the anchor. The nest may include a second surface spaced from a first surface of the anchor, the spacing between the first surface of the anchor and the second surface of the nest defining the gap. The first and second nest surfaces may be approximately parallel to one another. The nest may also include a third surface, where the first, second and third nest surfaces are compressed to different depths. The assembly may also include an insertion sheath that has a first end and is receptive of the closure device. The first end of the insertion sheath may include a monofold that fits in the gap between the nest and the anchor upon distal movement of the insertion sheath relative to the closure device. Alternatively, the anchor may include an indentation spaced from the first surface of the nest, the spacing between the indentation in the anchor and the first surface of the nest defining the gap.

p-0009In another embodiment the invention provides a tissue puncture closure assembly comprising another closure device for partial insertion into and sealing of an internal tissue wall puncture. The closure device includes a carrier tube having a split-level nest at a distal end, a filament extending through the carrier tube, and an anchor attached to the filament at the distal end of the carrier tube and seated in the split-level nest. The closure device may further include a sealing plug disposed inside the distal end of the carrier tube. The sealing plug is slidingly attached to the filament. The split-level nest may include a first nest surface adjacent to a first surface of the anchor, and a second nest surface spaced from the first surface of the anchor. The split-level nest may be a tri-level nest.

p-0010Another embodiment of the invention provides a tissue puncture closure device, the tissue puncture closure device comprising a carrier tube having a distal end, a sealing plug disposed inside the distal end of the carrier tube, a multi-level compression zone or area disposed in the distal end of the carrier, and an anchor seated in the multi-level compression area of the carrier. The multi-level compression area comprises a first compression zone at a first depth, and a second compression zone at a second depth, such that the anchor bears against the first compression zone and a first gap is formed between the anchor and the second compression zone. The multi-level compression zone may include a third compression zone at a third depth, such that a second gap larger than the first gap is formed between the anchor and the third compression zone.

p-0011Another embodiment of the invention provides a tissue puncture closure device assembly including a carrier tube having a distal end and a filament extending therethrough, a sealing plug disposed inside the distal end of the carrier tube and attached to the filament, an anchor attached to the filament at the distal end of the carrier tube, and a multi-level die for compressing a multi-level nest in the distal end of the carrier tube. The multi-level die includes a first level and a second level, the second level being higher than the first level. The multi-level die may include a third level, the third level being higher than the first and second levels.

p-0012Another aspect of invention provides a method of making a tissue puncture closure device including providing a carrier tube, threading a suture through the carrier tube, threading the suture through a sealing plug and an anchor, and crushing a multi-level nest into a distal end of the carrier tube. The method may also include nesting the anchor in the multi-level nest. The nesting may further comprise leaving a gap between a portion of the anchor and one level of the multi-level nest. The compression of the carrier tube may include engaging a multi-level die with the distal end of the carrier tube. The multi-level nest may include two or more different levels.

p-0013Another aspect of the invention provides a method of sealing a tissue puncture in an internal tissue wall accessible through a percutaneous incision. The method includes providing a tissue puncture closure device comprising a carrier tube with a filament extending therethrough. The filament is connected at a distal end of the carrier tube to an anchor, and the anchor is seated in a multi-level nest disposed in the carrier tube. The filament is also connected to a sealing plug located proximal of the anchor for disposition and anchoring about the tissue puncture. The method also includes inserting the tissue puncture closure device into the percutaneous incision, deploying the anchor into the tissue puncture, withdrawing the closure device from the percutaneous incision, and tamping the sealing plug toward the anchor. The step of deploying the anchor may further comprise sliding a formed monofold tip of an insertion sheath into a gap formed between the anchor and the multi-level nest disposed in the carrier tube.

p-0014Another aspect of the invention provides a method of reducing anchor shuttle in a subcutaneous tissue puncture sealing device comprising providing a gap between a carrier tube of the tissue puncture sealing device and the anchor by creating a multi-level nest in the carrier tube, where the anchor initially seats in the multi-level nest.

BRIEF DESCRIPTION OF THE DRAWINGS

p-0015The accompanying drawings illustrate various embodiments of the present invention and are a part of the specification. The illustrated embodiments are merely examples of the present invention and do not limit the scope of the invention.

p-0016<figref idrefs="DRAWINGS">FIG. 1A</figref> is a cut-away view of a tissue puncture closure device according to the prior art.

p-0017<figref idrefs="DRAWINGS">FIG. 1B</figref> is a detail of the cut-away section of <figref idrefs="DRAWINGS">FIG. 1A</figref>.

p-0018<figref idrefs="DRAWINGS">FIG. 2A</figref> is a top view of the tissue puncture closure device of <figref idrefs="DRAWINGS">FIG. 1A</figref> engaged with an insertion sheath in a first position according to the prior art.

p-0019<figref idrefs="DRAWINGS">FIG. 2B</figref> is a detailed cross-sectional view of the tissue puncture closure device and insertion sheath of <figref idrefs="DRAWINGS">FIG. 2A</figref>.

p-0020<figref idrefs="DRAWINGS">FIG. 3</figref> is a cross-sectional view of the tissue puncture closure device of <figref idrefs="DRAWINGS">FIG. 1A</figref> in relation to the insertion sheath of <figref idrefs="DRAWINGS">FIG. 2A</figref> in a second position according to the prior art.

p-0021<figref idrefs="DRAWINGS">FIG. 4</figref> is a cross-sectional view of the tissue puncture closure devices of <figref idrefs="DRAWINGS">FIG. 1A</figref> in relation to the insertion sheath of <figref idrefs="DRAWINGS">FIG. 2A</figref> in a third position according to the prior art.

p-0022<figref idrefs="DRAWINGS">FIG. 5</figref> is a perspective view of the tissue puncture closure device of <figref idrefs="DRAWINGS">FIG. 1A</figref> and insertion sheath of <figref idrefs="DRAWINGS">FIG. 2A</figref> shown in relation to a patient with an anchor deployed according to the prior art.

p-0023<figref idrefs="DRAWINGS">FIG. 6</figref> is a cross-sectional view of the tissue puncture closure device of <figref idrefs="DRAWINGS">FIG. 1A</figref> in relation to the insertion sheath of <figref idrefs="DRAWINGS">FIG. 2A</figref> in a fourth position illustrating shuttling according to the prior art.

p-0024<figref idrefs="DRAWINGS">FIG. 7</figref> is a cross-sectional view of a tissue puncture closure device according to one embodiment of the present invention.

p-0025<figref idrefs="DRAWINGS">FIG. 8</figref> is a cross-sectional view of the tissue puncture closure device of <figref idrefs="DRAWINGS">FIG. 7</figref> shown in relation to an insertion sheath in a first position according to one embodiment of the present invention.

p-0026<figref idrefs="DRAWINGS">FIG. 9</figref> is a cross-sectional view of the tissue puncture closure device of <figref idrefs="DRAWINGS">FIG. 7</figref> shown in relation to the insertion sheath of <figref idrefs="DRAWINGS">FIG. 8</figref> in a second position according to one embodiment of the present invention.

p-0027<figref idrefs="DRAWINGS">FIG. 10</figref> is a cross-sectional view of the tissue puncture closure device of <figref idrefs="DRAWINGS">FIG. 7</figref> shown in relation to the insertion sheath of <figref idrefs="DRAWINGS">FIG. 8</figref> in a third position according to one embodiment of the present invention.

p-0028<figref idrefs="DRAWINGS">FIG. 11</figref> is a cross-sectional view of the tissue puncture closure device of <figref idrefs="DRAWINGS">FIG. 7</figref> shown in relation to the insertion sheath of <figref idrefs="DRAWINGS">FIG. 8</figref> in a fourth position according to one embodiment of the present invention.

p-0029<figref idrefs="DRAWINGS">FIG. 12</figref> is a side view of a die component of a tissue puncture closure assembly according to one embodiment of the present invention.

p-0030<figref idrefs="DRAWINGS">FIG. 13</figref> is a cross-sectional view of a tissue puncture closure device according to another embodiment of the present invention.

p-0031<figref idrefs="DRAWINGS">FIG. 14</figref> is a side view of another die component of a tissue puncture closure assembly according to one embodiment of the present invention.

p-0032<figref idrefs="DRAWINGS">FIG. 15</figref> is a perspective view of the tissue puncture closure device of <figref idrefs="DRAWINGS">FIG. 7</figref> or <b>13</b> and the insertion sheath of <figref idrefs="DRAWINGS">FIG. 8</figref> shown in relation to a patient with an anchor deployed according to the present invention.

p-0033<figref idrefs="DRAWINGS">FIG. 16</figref> is a perspective view according to <figref idrefs="DRAWINGS">FIG. 15</figref> with an operator tamping a sealing plug according to the present invention.

p-0034Throughout the drawings, identical reference numbers designate similar, but not necessarily identical elements.

DETAILED DESCRIPTION

p-0035As mentioned above, vascular procedures are commonly performed throughout the world and require access to a lumen through a puncture. Most often, the lumen is a femoral artery. To close the puncture, many times a closure device is used to sandwich the puncture between an anchor and a sealing plug. However, there exists a possibility for the anchor to not deploy, disabling the function and negating the benefit of the device. The present invention describes methods and apparatus to reduce or eliminate non-deployment or “shuttle” of a closure device anchor. While the vascular instruments shown and described below include insertion sheaths and puncture sealing devices, the application of principles described herein to reduce anchor shuttle is not limited to the specific devices shown. The principles described herein may be used to reduce anchor shuttle for any vascular closure device. Therefore, while the description below is directed primarily to arterial procedures and certain embodiments of a vascular closure device, the methods and apparatus are only limited by the appended claims.

p-0036As used throughout the claims and specification the term “monofold” is used broadly to encompass any plastic deformation of a tube tip, especially a plastically deformed tube tip that forms a one-way valve with respect to an anchor. The term “approximately” or “substantially” means within ten percent of a given measurement or property. A “lumen” refers to any open space or cavity in a bodily organ, especially in a blood vessel. The words “including” and “having,” as used in the specification, including the claims, have the same meaning as the word “comprising.”

p-0037Referring now to the drawings, and in particular to <figref idrefs="DRAWINGS">FIGS. 1A-1B</figref>, a vascular puncture closure device <b>100</b> is shown according to the prior art. The vascular puncture closure device <b>100</b> includes a carrier tube <b>102</b> with a filament or suture <b>104</b> extending at least partially therethrough. External to the first or distal end <b>106</b> of the carrier tube is an anchor <b>108</b>. The anchor is an elongated, stiff, low profile member including an eye <b>109</b> formed at the middle. The anchor <b>108</b> is typically made of a biologically resorbable polymer.

p-0038The suture <b>104</b> is treaded through the anchor <b>108</b> and back to a collagen sponge <b>110</b>. The collagen sponge <b>110</b> is slidingly attached to the suture <b>104</b> as the suture passes distally through the carrier tube <b>102</b>, but as the suture traverses the anchor <b>108</b> and reenters the carrier tube <b>102</b>, it is securely slip knotted proximal to the collagen sponge <b>110</b> to facilitate cinching of the collagen sponge <b>110</b> when the closure device <b>100</b> is properly placed and the anchor <b>108</b> deployed (see <figref idrefs="DRAWINGS">FIG. 5</figref>).

p-0039The carrier tube includes a tamping tube <b>112</b> disposed therein. The tamping tube <b>112</b> is slidingly mounted on the suture <b>104</b> and may be used by an operator to tamp the collagen sponge <b>110</b> toward the anchor <b>108</b> at an appropriate time to plug a percutaneous tissue puncture.

p-0040At the distal end <b>106</b> of the carrier tube <b>102</b> is a nest <b>114</b>. Prior to deployment of the anchor <b>108</b> within an artery, the eye <b>109</b> rests outside the distal end <b>106</b> of the carrier tube <b>102</b>, and one end <b>116</b> of the anchor <b>108</b> rests in the nest <b>114</b>. The nest <b>114</b> is typically compressed or crushed to a depth such that a second surface <b>118</b> of the anchor <b>108</b> is flush with the outer diameter of the carrier tube <b>102</b>. The nest <b>114</b> is compressed to a length that is longer than the end <b>116</b> of the anchor <b>108</b>. The anchor <b>108</b> may be temporarily held in place in the nest <b>114</b> by a bypass tube <b>117</b> disposed over the distal end <b>106</b> of the carrier tube <b>102</b>.

p-0041The flush arrangement of the anchor <b>108</b> and carrier tube <b>102</b> allows the anchor to be inserted into an insertion sheath <b>220</b> as shown in <figref idrefs="DRAWINGS">FIG. 2A-2B</figref>, and eventually through an arterial puncture <b>501</b> (shown in <figref idrefs="DRAWINGS">FIG. 5</figref>). However, the bypass tube <b>117</b> includes an oversized head <b>119</b> that prevents the bypass tube <b>117</b> from passing through an internal passage <b>221</b> of the insertion sheath <b>220</b>. Therefore, as the puncture closure device <b>100</b> is inserted into the internal passage <b>221</b> of the insertion sheath <b>220</b>, the oversized head <b>119</b> bears against a surface <b>223</b> of insertion sheath. Further insertion of the puncture closure device <b>100</b> results in sliding movement between the carrier tube <b>102</b> and the bypass tube <b>117</b>, releasing the anchor <b>108</b> from the bypass tube <b>117</b>. However, the anchor <b>108</b> remains in the nest <b>114</b> following release from the bypass tube <b>117</b>, limited in movement by the insertion sheath <b>220</b>.

p-0042The insertion sheath <b>220</b> includes a first end <b>222</b> having a monofold <b>224</b>. The monofold <b>224</b> acts as a one-way valve to the anchor <b>108</b>. As shown in <figref idrefs="DRAWINGS">FIGS. 2A-2B</figref> and <b>3</b>, the monofold <b>224</b> is a plastic deformation in a portion of the insertion sheath <b>220</b> that elastically flexes as the anchor <b>108</b> is pushed out through the first end <b>222</b> of the insertion sheath <b>220</b>. However, as the anchor <b>108</b> passes though and out of the first end <b>222</b> of the insertion sheath <b>220</b> as shown in <figref idrefs="DRAWINGS">FIG. 3</figref>, the monofold <b>224</b> attempts to spring back to its original deformed position and a biased tip <b>226</b> of the monofold <b>224</b> engages the nest <b>114</b>. As relative movement between the carrier tube <b>102</b> and the insertion sheath <b>220</b> continues, the biased tip <b>226</b> traverses the contour <b>128</b> of the carrier tube nest <b>114</b> in a proximal direction.

p-0043Typically, after the anchor <b>108</b> passes through the first end <b>222</b> of the insertion sheath <b>220</b> and enters an artery <b>530</b> (<figref idrefs="DRAWINGS">FIG. 5</figref>), the puncture closure device <b>100</b> is pulled in a proximal direction with respect to the insertion sheath <b>220</b>. The biased tip <b>226</b> of the monofold <b>224</b> thus follows the contour <b>128</b> and usually slides distally between the anchor <b>108</b> and the nest <b>114</b>, causing the anchor to rotate as shown in <figref idrefs="DRAWINGS">FIG. 4</figref>. Accordingly, if all goes well, the anchor <b>108</b> is deployed within the artery as shown in <figref idrefs="DRAWINGS">FIG. 5</figref> and does not reenter the insertion sheath <b>220</b>.

p-0044However, because the end <b>116</b> of the anchor <b>108</b> normally bears directly against the nest <b>114</b>, sometimes the biased tip <b>226</b> of the monofold <b>224</b> slides over the anchor <b>108</b> as shown in <figref idrefs="DRAWINGS">FIG. 6</figref> when the closure device <b>100</b> is pulled proximally with respect to the insertion sheath <b>220</b> instead of sliding between the end <b>116</b> and nest <b>114</b>. Thus, rather than deploying properly within the artery, the anchor <b>108</b> is sometimes reinserted into the insertion sheath <b>220</b>, and the puncture closure device <b>100</b> fails.

p-0045Therefore, according to some embodiments of the present invention, a tissue closure device <b>700</b> includes a modified carrier tube <b>702</b> as shown in <figref idrefs="DRAWINGS">FIG. 7</figref>. The modified carrier tube <b>702</b> includes a split-level or multi-level nest <b>714</b> at the first or distal end <b>706</b>. When the anchor is seated in a first or insertion position as shown, the multi-level nest <b>714</b> of <figref idrefs="DRAWINGS">FIG. 7</figref> includes a first surface <b>732</b> that is adjacent to a first surface <b>734</b> of the anchor <b>108</b>. However, the multi-level nest also includes a second surface <b>736</b> that is spaced from the first surface of the anchor <b>108</b>, creating a gap <b>738</b> between a portion of the end <b>116</b> of the anchor <b>108</b> and the second surface <b>736</b> of the nest <b>714</b>. The first and second surfaces <b>732</b>, <b>736</b> are substantially parallel to one another as shown, but this is not necessarily so.

p-0046Referring next to <figref idrefs="DRAWINGS">FIGS. 8-9</figref>, a tissue closure assembly <b>800</b> includes the tissue closure device <b>700</b> and the insertion sheath <b>220</b>. As the closure device <b>700</b> is inserted through the insertion sheath <b>220</b>, the anchor <b>108</b> impinges and deforms the monofold <b>224</b> in a manner similar to that described above with reference to <figref idrefs="DRAWINGS">FIG. 3</figref>. However, as the anchor passes out of the insertion sheath <b>220</b> as shown in <figref idrefs="DRAWINGS">FIG. 10</figref>, the monofold <b>224</b> springs back and impinges on the second surface <b>736</b> spaced from the first surface <b>734</b> of the anchor <b>108</b> instead of the first surface <b>732</b> that the anchor <b>108</b> bears against. Accordingly, as the tissue closure device <b>700</b> is pulled back into the insertion sheath <b>220</b>, the tip <b>226</b> of the monofold slips easily into the gap <b>738</b>, advantageously reducing or eliminating any possibility of the anchor <b>108</b> sliding back into the insertion sheath <b>220</b>. Therefore, as the closure device <b>700</b> is pulled proximally with respect to the insertion sheath <b>220</b>, the anchor rotates and deploys as shown in <figref idrefs="DRAWINGS">FIG. 11</figref>.

p-0047The multi-level nest <b>714</b> may be created, for example, by heating and/or compressing or crushing the first end <b>706</b> of the carrier tube <b>702</b> with a die, such as the anvil <b>1240</b> shown in <figref idrefs="DRAWINGS">FIG. 12</figref>. Therefore, the anvil <b>1240</b> may also be part of the tissue closure assembly <b>800</b>. The anvil <b>1240</b> is made of structural materials such as steel and may include a first level <b>1242</b> and a second level <b>1244</b>. According to the embodiment of <figref idrefs="DRAWINGS">FIG. 12</figref>, the second level <b>1244</b> is higher than the first level <b>1242</b> by a predetermined distance D<b>1</b>. D<b>1</b> may range between approximately 0.01 and 0.030 inches, preferably about 0.020 inches. The first and second levels <b>1242</b>, <b>1244</b> are each higher than a main level <b>1246</b> and correspond to compression zones in the carrier tube <b>702</b> (<figref idrefs="DRAWINGS">FIG. 7</figref>) that result in the first and second surfaces <b>732</b>, <b>736</b> (<figref idrefs="DRAWINGS">FIG. 7</figref>) of the nest <b>714</b> (<figref idrefs="DRAWINGS">FIG. 7</figref>). The second level <b>1244</b> is higher than the main level <b>1246</b>. Normally, the main level <b>1246</b> does not crush or impinge on the carrier tub <b>702</b> (<figref idrefs="DRAWINGS">FIG. 7</figref>), but instead limits the compression caused by the first and second levels <b>1242</b>, <b>1244</b>. The first level <b>1242</b> is offset from the second level <b>1244</b> by a second distance D<b>2</b>. D<b>2</b> may range between approximately 0.030 and 0.080 inches, preferably about 0.055 inches. Other methods of creating the nest <b>714</b> (<figref idrefs="DRAWINGS">FIG. 7</figref>) may also be used.

p-0048The present invention is not limited to the split-level configuration for the nest <b>714</b> as shown in <figref idrefs="DRAWINGS">FIG. 7</figref>. For example, according to <figref idrefs="DRAWINGS">FIG. 13</figref> there is another tissue puncture closure device <b>1300</b> shown. The tissue puncture closure device <b>1300</b> includes a carrier tube <b>1302</b> with a multi-level nest <b>1314</b> comprising three spaced surfaces <b>1332</b>, <b>1336</b>, <b>1337</b>, respectively, that are generally parallel with one another. The three spaced surfaces <b>1332</b>, <b>1336</b>, <b>1337</b> create a tiered gap <b>1338</b> may include first and second gaps <b>1339</b> and <b>1341</b>, and may even further ensure that the monofold <b>224</b> (<figref idrefs="DRAWINGS">FIG. 2B</figref>) or other one-way valve will not allow the anchor <b>108</b> to reenter the insertion sheath <b>220</b> (<figref idrefs="DRAWINGS">FIG. 2B</figref>) once it has passed therethrough. Other multi-level nests may also be used to create more than three surfaces, if desired.

p-0049The multi-level nest <b>1314</b> may be formed by heating and/or compressing the carrier tube (not shown in <figref idrefs="DRAWINGS">FIG. 13</figref>) with a die, such as the anvil <b>1440</b> shown in <figref idrefs="DRAWINGS">FIG. 14</figref>. Therefore, the anvil <b>1440</b> may also be part of the tissue closure assembly <b>800</b> (<figref idrefs="DRAWINGS">FIG. 15</figref>). According to the embodiment of <figref idrefs="DRAWINGS">FIG. 14</figref>, the anvil <b>1440</b> includes a first level <b>1442</b>, a second level <b>1444</b>, and a third level <b>1445</b>. The second level <b>1444</b> is higher than the first level <b>1442</b>, and the third level <b>1445</b> is higher than the second level <b>1444</b>. All three levels <b>1442</b>, <b>1444</b>, <b>1445</b> are higher than a main level <b>1446</b> and correspond to the first, second and third surfaces or compression zones <b>1332</b>, <b>1336</b>, <b>1337</b>, respectively, of the carrier tube (not shown in <figref idrefs="DRAWINGS">FIG. 13</figref>).

p-0050The embodiments shown in <figref idrefs="DRAWINGS">FIGS. 8 and 13</figref> may include similar or identical elements shown in <figref idrefs="DRAWINGS">FIGS. 1-2</figref>. For example, referring to <figref idrefs="DRAWINGS">FIG. 15</figref>, the closure device <b>800</b> (and <b>1300</b> in <figref idrefs="DRAWINGS">FIG. 13</figref>) may include the suture <b>104</b> (or other filament) extending from the first end <b>106</b> of the closure device <b>800</b>, a sealing plug such as the collagen sponge <b>110</b> slidingly attached to the suture <b>104</b> and the tamping tube <b>112</b>. <figref idrefs="DRAWINGS">FIG. 15</figref> shows the closure device <b>800</b> inserted partially through a puncture <b>162</b> in an artery <b>160</b>, with the anchor <b>108</b> and the collagen sponge <b>110</b> deployed.

p-0051Referring to <figref idrefs="DRAWINGS">FIGS. 15-16</figref>, a method of sealing the puncture <b>160</b> according to the present invention may include inserting the tissue puncture closure device <b>800</b> into a percutaneous incision <b>164</b> and deploying the anchor <b>108</b> into the tissue puncture <b>162</b> as shown in <figref idrefs="DRAWINGS">FIG. 15</figref>. The method may also include withdrawing the closure device <b>800</b> from the percutaneous incision <b>164</b> and tamping the sealing plug <b>110</b> toward the anchor <b>108</b> with the tamping tube <b>112</b>. The step of deploying the anchor may further comprise sliding the monofold tip <b>226</b> (<figref idrefs="DRAWINGS">FIGS. 3-4</figref>) of the insertion sheath <b>220</b> into the gap <b>738</b> (<figref idrefs="DRAWINGS">FIG. 7</figref>) formed between the anchor <b>108</b> and the multi-level nest <b>714</b> (<figref idrefs="DRAWINGS">FIG. 7</figref>) disposed in the carrier tube <b>702</b>.

p-0052While the invention has been particularly shown and described with reference to embodiments thereof, it will be understood by those skilled in the art that various other changes in the form and details may be made without departing from the scope of the invention.